BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHLORAPREP ONE STEP FREPP

    MDR report key: 11884470 · Received May 26, 2021

    Report

    Report Number
    3004932373-2021-00257
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 11, 2021
    Report Date
    August 23, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD FOR PN 930299 LN 0324920 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO BROKEN AMPOULE DURING THE MANUFACTURING OF THIS LOT. BASED ON NO PHOTOGRAPH OR SAMPLE WAS RECEIVED FOR ANALYSIS FROM THE CUSTOMER, THE FAILURE MODE COULD NOT BE CONFIRMED. THE AMPOULE IS MADE OF GLASS AND IS DESIGNED TO BREAK AT A RELATIVELY LOW BREAK FORCE. WHEN PRESSURE IS APPLIED TO THE WINGS BY A PINCHING FORCE WITH THE FINGERS, THIS ACTIVATES THE APPLICATOR; BREAKING THE GLASS AMPOULE AND RELEASING THE CHLORAPREP SOLUTION ONTO THE FOAM TIP. FOLLOW UP EMDR (B)(4). H3 OTHER TEXT: SEE NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL NO.: 930299. BATCH NO.: 0324920. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE APPLICATOR DOES NOT HAVE ENOUGH LIQUID OR WAS UNDERFILLED TO ACCOMPLISH PROPER CLEANING OF THE SITE. DESCRIPTION: THE ED TECH REPORTED WHILE GETTING BLOOD CULTURES THE PREP DID NOT HAVE ENOUGH LIQUID OR WAS UNDERFILLED TO ACCOMPLISH PROPER CLEANING OF THE SITE TO AVOID CONTAMINATED SAMPLES. MULTIPLE PREPS WERE NEEDED (4). THIS IS IN RESPONSE TO BACKORDERS WITH THE ORIGINAL 3ML PRODUCT RECALL/BACKORDER. SITE HAS HAD TO USE 10 ML SUB #930700 TO ACCOMPLISH A LONG ENOUGH DRY TIME FOR EFFECTIVE BLOOD CULTURE COLLECTION/DRAWS.

    Additional Manufacturer Narrative · 1

    (B)(4). PR (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MATERIAL NO.: 930299, BATCH NO.: 0324920. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE APPLICATOR DOES NOT HAVE ENOUGH LIQUID OR WAS UNDERFILLED TO ACCOMPLISH PROPER CLEANING OF THE SITE. DESCRIPTION: THE ED TECH REPORTED WHILE GETTING BLOOD CULTURES THE PREP DID NOT HAVE ENOUGH LIQUID OR WAS UNDERFILLED TO ACCOMPLISH PROPER CLEANING OF THE SITE TO AVOID CONTAMINATED SAMPLES. MULTIPLE PREPS WERE NEEDED (4). THIS IS IN RESPONSE TO BACKORDERS WITH THE ORIGINAL 3ML PRODUCT RECALL/BACKORDER. SITE HAS HAD TO USE 10 ML SUB #930700 TO ACCOMPLISH A LONG ENOUGH DRY TIME FOR EFFECTIVE BLOOD CULTURE COLLECTION/DRAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782582 CHLORAPREP ONE STEP FREPP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION 213, LLC 0113 0324920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other